Morning-Only 4 L PEG vs Split Dose Prep for Afternoon Colonoscopies, Endoscopist-Blinded Prospective Study

Morning-Only 4 Liter Polyethylene Glycol vs. Split Dose for Afternoon Colonoscopies, a Randomized Endoscopist-Blinded Prospective Study

Comparison of quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy procedure.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Same day 4 L preparation (Polyethylene Glycol); Drug: Split dose 4 L preparation (Polyethylene Glycol)

Detailed Description

The aim of colorectal cancer screening is to reduce mortality. This can be effectively achieved by colonoscopy with direct visualization of the entire colon to detect preneoplastic lesions such as adenomatous polyps. Bowel preparation quality is critical for the accuracy of colonoscopy, time required to complete the procedure and its success. On the other hand, poor quality of bowel preparation was shown to be associated with a lower adenoma detection rate. Prior studies have shown that time of colonoscopy is one of the major factors influencing bowel preparation quality with the afternoon colonoscopies being notable for a high failure rate. This failure rate is related to poor bowel preparation quality. Given that, the number of afternoon colonoscopies performed is still high due to the increased need for colonoscopies. Therefore, it is suggested that improving the bowel preparation quality can reduce failure rate of afternoon colonoscopies. Several studies on split-dose bowel preparation have shown that it is superior to the conventional day-before regimen, in terms of preparation quality and patient's tolerability. Another study on split-dose bowel preparation also showed that it is associated with a better adenoma detection rate, better polyp detection rate and colonoscopy completion rate. There also have been few studies comparing same day dose vs. day-before for afternoon colonoscopies and showed that same day was superior to day before.There is no data comparing quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split-dose preparation for an afternoon colonoscopy.

Using a 4L PEG-ELS solution, the investigators aim to evaluate the efficacy and patient's tolerability for the same day versus split-dose regimen.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All patients above 18 years of age undergoing elective outpatient colonoscopy at CCF Florida who are scheduled for an afternoon colonoscopy procedure. All patients must have been prescribed a 4 L PEG based bowel preparation.

Exclusion Criteria:

1. Patients who had prior Colectomy or colon resection surgery.
2. Patients with confirmed diagnosis of impaired GI motility.
3. Chronic nausea or vomiting.
4. Severe constipation (=/<1 bowel movement per week).
5. Pregnancy.
6. Breast feeding.
7. Patients taking drugs which are known to influence GI motility.
8. Hospital inpatients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Same day 4 L preparation of PEG; Receive 1 gallon (4 L) of Polyethylene Glycol (PEG) preparation on the morning of the colonoscopy.	Drug: Same day 4 L preparation (Polyethylene Glycol); Receive 1 gallon (4 L) of Polyethylene Glycol preparation on the morning of the colonoscopy.; Other Names: PEG bowel prep
Active Comparator: Split dose 4 L preparation of of the PEG; Receive the split-dose regimen. Will take half (2 L) of the PEG preparation the evening before colonoscopy and half (2 L) of the PEG preparation on the morning of the procedure.	Drug: Split dose 4 L preparation (Polyethylene Glycol); Receive the split-dose regimen. Will take half (2 L) the preparation the evening before colonoscopy and half (2 L) on the morning of the procedure.; Other Names: PEG bowel prep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of preparation (Ottawa score)	The quality of bowel preparation will be assessed for the 2 groups at the time of the colonoscopy using the Ottawa score for quality of preparation.	During the colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with the bowel preparation (questionnaire).	Patient satisfaction with the bowel preparation in the 2 groups will be assessed using an approved questionnaire at the time of pre-operative assessment of the patient.	Before the colonoscopy procedure.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Fernando Castro, M.D., Cleveland Clinic Florida

Publications and helpful links

General Publications

• Castro FJ, Al-Khairi B, Singh H, Mohameden M, Tandon K, Lopez R. Randomized Controlled Trial: Split-dose and Same-day Large Volume Bowel Preparation for Afternoon Colonoscopy Have Similar Quality of Preparation. J Clin Gastroenterol. 2019 Nov/Dec;53(10):724-730. doi: 10.1097/MCG.0000000000001213.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: FLA 15-092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO